Bioequivalence and Bioavailability Forum • Reversed procedure?

Reversed procedure? [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2018-07-03 17:33 (2263 d 12:39 ago) – Posting: # 19012
Views: 32,647

Hi Outlaw Torn,

I agree. The original ideas behind BCS-based biowaiver were:

BE-studies of solutions are not required.
If an oral formulation behaves like a solution, BE-studies could be waived.

#1 was applied for ages. Only recently certain conditions about excipients were added.
Which conditions have to be applied for #2 depends on the BCS class, excipients, no NTID, :blahblah:

I see no scientific reason why the procedure should not be reversed (test = solution, reference = IR).

❝ Science and regulations really are strange bedfellows.

Yep.

❝ Maybe Helmet can bring this subject up at the BioBridges conference during the discussion on ICH M9 (hint, hint, nudge, nudge). ;-)

Helmut ≠ Helmet (watch [image]

this).
Henrike Potthast worked on ICH M9. She is always open for discussions. Why don’t you go there and ask her yourself? At trip to Prague is way cheaper than an in vivo study. ;-)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

BCS III Classification Obinoscopy 2018-04-20 08:09 [Dissolution / BCS / IVIVC]
- BCS-based biowaivers for Class III Helmut 2018-04-20 12:15
  - BCS-based biowaivers for Class III Obinoscopy 2018-04-20 16:06
  - BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 09:48
    - BCS-based biowaivers for Class III nobody 2018-06-21 10:33
      - BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 12:11
      - BCS-based biowaivers for Class III: Syrups Helmut 2018-06-21 12:21
        
        BCS-based biowaivers for Class III: Syrups The Outlaw Torn 2018-06-21 12:47
        
        BE of solutions Helmut 2018-06-21 13:33
        
        BE of solutions The Outlaw Torn 2018-06-21 13:39
        BE of solutions The Outlaw Torn 2018-06-27 15:22
        
        Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study Obinoscopy 2018-07-01 02:06
        
        Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study The Outlaw Torn 2018-07-03 15:02
        
        Reversed procedure?Helmut 2018-07-03 15:33
        
        Reversed procedure? The Outlaw Torn 2018-07-04 11:50
        
        BioBridges Helmut 2018-07-04 12:03